PMCF Study of the CE-marked Drainova® ArgentiC Catheter

Launched by EWIMED GMBH · May 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the Drainova® ArgentiC Catheter, a device used to help remove excess fluid from the body, specifically in conditions like pleural effusion and ascites. The study aims to see how well this catheter works during regular treatments and to check if there are any new safety concerns. Researchers want to know if the catheter effectively improves patients' symptoms and if it functions properly as intended.

To participate, individuals must be at least 18 years old and able to give informed consent. However, certain health conditions, such as infections in the body cavity or known allergies to materials used in the catheter, may prevent someone from joining the study. Participants will share their experiences regarding symptom relief and any issues they may encounter with the catheter during the trial. This study is currently looking for volunteers to help gather important information about the device and its performance in real-life clinical settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥ 18 years old
• • Patients being able to give informed consent
• Exclusion Criteria:
• Patients with any contraindication according to the IFU:
• • presence of septa in the body cavity
• • coagulopathy
• • infection in the body cavity
• • lymphatic effusion
• • shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion)
• • known allergies to any of the materials used in the drainage product

Trial Officials